Ozempic

Product manufactured by Remedyrepack Inc.

Application Nr Approved Date Route Status External Links
NDA209637 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ozempic Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [See Clinical Studies ( 14.1 )] . Limitations Of Use Ozempic Is Not Recommended As A First-Line Therapy For Patients Who Have Inadequate Glycemic Control On Diet And Exercise Because Of The Uncertain Relevance Of Rodent C-Cell Tumor Findings To Humans [See Warnings And Precautions ( 5.1 )] . Ozempic Has Not Been Studied In Patients With A History Of Pancreatitis. Consider Other Antidiabetic Therapies In Patients With A History Of Pancreatitis [See Warnings And Precautions ( 5.2 )] . Ozempic Is Not A Substitute For Insulin. Ozempic Is Not Indicated For Use In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Patients With Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. Ozempic Is A Glucagon-Like Peptide 1 (Glp-1) Receptor Agonist Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus ( 1 ). Limitations Of Use: Not Recommended As First-Line Therapy For Patients Inadequately Controlled On Diet And Exercise ( 1 , 5.1 ). Has Not Been Studied In Patients With A History Of Pancreatitis. Consider Another Antidiabetic Therapy ( 1 , 5.2 ). Not Indicated For Use In Type 1 Diabetes Mellitus Or Treatment Of Diabetic Ketoacidosis ( 1 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Semaglutide

Comments